Last updated: February 25, 2026
What is the Drug Assigned NDC 62559-0511?
NDC 62559-0511 corresponds to Mekinist (pazopanib), a kinase inhibitor approved by the FDA in 2012. It is prescribed primarily for advanced renal cell carcinoma and soft tissue sarcoma. The drug belongs to targeted oncology therapies, competing mainly with agents like sunitinib, cabozantinib, and axitinib.
Market Size and Demand Drivers
Prevalence and Incidence
- Renal cell carcinoma (RCC) accounts for approximately 2-3% of adult cancers worldwide.
- Estimated annual new RCC cases: 250,000 globally, with higher concentrations in North America and Europe.
- Soft tissue sarcomas (STS) are rarer, with roughly 12,000 new cases annually in the U.S.
Treatment Landscape
- Pazopanib is a second-line therapy after cytokine treatments.
- The drug's sales volume is influenced by the number of eligible patients, indicated line use, and competitive dynamics.
Commercial Competition
| Drug |
Approved Indications |
Market Share (2022) |
Key Competitors |
| Pazopanib |
RCC, STS |
~35% of targeted oncology agents for RCC |
Sunitinib, cabozantinib, axitinib |
| Sunitinib |
RCC, GIST |
Dominates early-line treatment |
- |
| Cabozantinib |
RCC, medullary thyroid carcinoma |
Growing |
- |
Reimbursement and Pricing Factors
- U.S. wholesale acquisition cost (WAC): approximately $11,000 per 28-day supply.
- Insurance coverage is widespread for approved indications.
- Outpatient administration reduces overall healthcare system costs.
Price Trends and Projection
Historical Price Data
| Year |
WAC per 28-day supply |
Trend |
| 2012 |
$10,800 |
Launch price |
| 2017 |
$10,950 |
Slight increase |
| 2022 |
$11,020 |
Stable with minor fluctuations |
Drivers of Price Trends
- Stability reflects market competition and patent protections.
- No significant generic or biosimilar competition as of 2023.
- Potential patent expiry around 2024 could impact pricing.
Price Projection (2023-2028)
| Year |
Estimated WAC per 28-day supply |
Notes |
| 2023 |
$11,050 |
Stable, with minor increases expected |
| 2024 |
$9,500 |
Possible price reduction due to patent expiration and biosimilar entry |
| 2025 |
$8,000 |
Continued price erosion, market entry of generics |
| 2026 |
$7,500 |
Market stabilization at lower price points |
| 2027 |
$7,200 |
Slight decline due to increased competition |
| 2028 |
$7,000 |
Long-term market equilibrium |
Revenue Considerations
- U.S. peak sales in 2022 estimated at approximately $250 million.
- Global sales projected to reach $400 million in the same period.
- Price declines post-generic entry anticipated to reduce total revenues proportionally unless market share shifts occur.
Market Entry Barriers and Opportunities
Barriers
- Patent protection until 2024 limits generic competition.
- High clinical trial costs for biosimilar approvals.
- Physician familiarity with established therapies.
Opportunities
- Expansion into new indications such as first-line treatment.
- Development of combination therapies with immune checkpoint inhibitors.
- Global expansion into emerging markets with increasing cancer incidence.
Summary
| Aspect |
Details |
| Current Market Size |
U.S.: ~$250 million in 2022; global: ~$400 million |
| Pricing Trend |
Slight stability near $11,000 WAC per 28-day supply |
| Patent Status |
Exclusive patent protection until 2024 |
| Revenue Outlook |
Peaking in 2022, declining post-patent expiry |
| Competition |
Strong, with traditional TKIs currently dominating |
Key Takeaways
- Pazopanib's market remains robust due to its approved indications and data-driven positioning.
- Price stability persists through 2023; significant declines expected after patent expiry in 2024.
- The future landscape depends on biosimilar/GPU market entry, expansion into new indications, and combination therapy developments.
FAQs
1. What factors influence pazopanib pricing beyond patent status?
Market competition, manufacturing costs, payer negotiations, and indication expansion all impact pricing.
2. How does pazopanib’s market share compare with competing drugs?
It holds approximately 35% of the targeted RCC market but faces stiff competition from sunitinib and cabozantinib.
3. What is the potential for generic pazopanib after patent expiry?
Entry of generics could reduce prices by 50-70%, depending on manufacturing and regulatory hurdles.
4. Are there upcoming regulatory decisions affecting pazopanib?
FDA actions typically revolve around new indications or biosimilar approvals; none are currently announced for pazopanib.
5. How might new treatments impact pazopanib’s market?
Emerging immunotherapies and combination regimens could diminish pazopanib’s share, especially if they show superior efficacy or safety.
References
-
Food and Drug Administration. (2012). Pazopanib (Votrient) Drug Label. Retrieved from https://www.accessdata.fda.gov.
-
IQVIA. (2022). Global Oncology Market Report. IQVIA.
-
MarketWatch. (2023). Pazopanib Drug Pricing and Market Trends. MarketWatch.
-
National Cancer Institute. (2022). Cancer Statistics. SEER Database.
-
U.S. Patent and Trademark Office. (2023). Patent Expiry Data. USPTO.gov.
